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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K880165
Device Name TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
Applicant
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Applicant Contact RAYMOND GOULD
Correspondent
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Correspondent Contact RAYMOND GOULD
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received01/13/1988
Decision Date 03/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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